Diagnostic Capacity of Keratoconus Match Index and Keratoconus Match Probability in Forme Fruste Keratoconus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-07-31

Brief Summary

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Primary objective of this study was to evaluate the diagnostic capability of keratoconus match index (KMI) and keratoconus match probability (KMP) indexes in forme fruste keratoconus (FFK), and their association with a series of Pentacam-derived keratconus (KC) indexes. KMI and KMP parameters are KC-specifc indexes that are measured by Ocular Response Analyzer (ORA), based on the distinct ORA-derived waveform characteristics of KC eyes.

Study participants were recruited from the Cornea Outpatient service in a consecutive if eligible basis. Two study groups were formed: a) FFK group (FFKG) that included patients diagnosed with FFK, and, b) Control group (CG) was formed by refractive surgery candidates.

All ORA (Reichert Ophthalmic Instrument, Buffalo, NY, USA, software version: 3.01)and Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same experienced operator in a consistent way

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Detailed Description

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Conditions

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Forme Fruste Keratoconus (FFK)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Forme Fruste Keratoconus Group (FFKG)

Forme Fruste Keratoconus Group (FFKG) included patients diagnosed with FFK.

No interventions assigned to this group

Control Group (CG)

Control group(CG) was formed by refractive surgery candidates.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* diagnosis of keratoconus KC in the fellow eye according to the Amsler-Krumleich criteria (FFKG)
* KISA index between 60 and 100% in the FFK eye (FFKG)
* lack of any KC-related findings / signs in the slit-lamp biomicroscopy (FFKG)
* uneventful ophthalmologic history (CG)
* no indications of corneal pathology in slit-lamp biomicroscopy and Placido disk-based videokeratography (CG)
* KISA index value less than 60% (CG)

Exclusion Criteria

for both study groups:

* previous incisional eye surgery
* corneal scars and opacities
* history of herpetic keratitis, severe eye dryness
* pregnancy or nursing
* current corneal infection
* glaucoma
* suspicion for glaucoma
* IOP lowering treatment
* underlying autoimmune disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No